By Mary Holland, JD, and Robert Krakow, JD

Vaccines, like all prescription medicines, carry risks—the law considers them to be “unavoidably unsafe.”1 Because the government and medical community want to ensure high vaccination rates, they do not publicize this legal fact. To the contrary, they tell the public that “vaccines are safe and effective.”2The public is lulled into believing that vaccines are almost perfectly risk free. That, however, is public relations.

Congress passed the 1986 National Childhood Vaccine Injury Act (“the Act”) in part to compensate families for “vaccine-related injury or death.”3 The Act includes a Vaccine Injury Table listing brain damage, paralytic disorders, anaphylaxis, seizures, and death, which are the basis for compensation if they occurred within specific time periods after vaccination.4 The Act establishes a National Vaccine Injury Compensation Program (VICP) to compensate injured children for specified “on-table” injuries and for “off-table” injuries where the petitioners can prove causation.

In the name of protecting children’s health, the Act changed the legal landscape fundamentally. Instead of keeping doctors and the vaccine industry directly liable for adverse reactions to vaccines, the Act created a taxpayer-financed compensation program for injuries. Unprecedented at that time, the Act was, in effect, a corporate bailout for the pharmaceutical industry, forcing the public—rather than the industry—to pay for damage from “unavoidably unsafe” products. Thus the Act deprived children of two of the most significant legal protections they had to ensure safety and remedial compensation: informed consent and the right to sue manufacturers directly.

The U.S. Department of Justice (DOJ) represents the Department of Health and Human Services (HHS) in claims of vaccine-induced injury or death before the U.S. Court of Federal Claims. Neither the vaccine industry nor doctors are defendants in the VICP. So far, HHS has compensated about 2,500 claims of vaccine-induced injury and has committed over $2 billion in compensation and legal fees.5

The idea behind the compensation program is simple—if children are injured in the “war on disease,” society has an ethical duty to care for them, just as society has a duty to care for soldiers injured while serving in the military. Congress gave bipartisan support to the Act and intended for compensation to be quick, easy, certain, and generous. In principle, there was congressional and public consensus that caring for vaccine-injured children was the right thing to do.6

The reality has not lived up to the principle. The message that “vaccines are safe and effective” does not reflect the reality that vaccines injure and cause death. Due to this tension, perhaps, the government goes to great lengths to compensate as few cases as possible, maintaining the fallacy that vaccine-induced injury occurs in a vanishingly rare number of cases.

If a parent or guardian asserts that vaccines caused his or her child’s injury,

they [the DOJ] will deny your reality. They’ll deny your word. They’ll say you’re lying. They’ll say you made it up. They’ll say you’re mistaken. They’ll say you’re very well-educated so you know how to game the system. And then you’ll come up against the full weight of their authority—expert witnesses with unlimited funds who will say that your child’s injury is genetic, genetic, genetic. You’ll find obstruction in the Department of Justice. You’ll find resistance. And you’ll find scorn.7

The VICP has been a dismal failure. Almost four out of five claimants lose in what was meant to be a petitioner-friendly administrative forum.8 The tenor of VICP proceedings is exceptionally hostile and adversarial—the exact opposite of what Congress intended. Petitioners must litigate almost every case—almost no injuries are “on-table” administrative claims anymore. Though Congress intended cases to resolve within a year, cases now take many years to litigate.

There is a long list of things that are wrong with the VICP. First and foremost, while it is referred to as a court, it simply is not a court. There is no judge, no jury, no right to require the adversary to provide information, and no formal rules of evidence and civil procedure. It is an administrative tribunal meant to handle simple injury cases based on certain presumptions. In a completely inappropriate way, the VICP is being used today as a forum for exceedingly complex health litigation, such as the Omnibus Autism Proceeding.9 The VICP is woefully inadequate for handling such litigation.

The following list outlines some of the major problems with the VICP.

1. THE LACK OF JUDICIAL INDEPENDENCE.

In lieu of judges, the U.S. Court of Federal Claims appoints “Special Masters” to decide questions of fact and law and oversee VICP proceedings. The U.S. Court of Federal Claims and the U.S. Court of Appeals for the Federal Circuit only review legal decisions for abuse of discretion and factual mistakes. Special Masters do not have the kind of judicial independence they need to decide these extremely controversial and serious cases. They are appointed to four-year terms, they have no specialized training in medicine, they primarily come from governmental law jobs, and they sometimes appear to defer to the DOJ and HHS.10 Decisions in cases like the Omnibus Autism Proceeding potentially affect national vaccination policy. Special Masters, lacking the life tenure of judges or even long-term appointments, are not suited to make decisions that might affect federal policy.

2. THE LACK OF EQUALITY BETWEEN THE GOVERNMENT AND PETITIONERS.

There are gross financial inequalities between the DOJ and petitioners in these cases. The DOJ has a virtually unlimited budget and can unilaterally retain and pay for expert witnesses. The VICP pays the petitioners’ experts’ and lawyers’ fees, but there’s a catch: The VICP often compensates petitioners’ lawyers years after a case has started. Moreover, the DOJ and the U.S. Court of Federal Claims have the opportunity to review and cut petitioners’ legal fees. There is no reciprocal right for petitioners’ lawyers to review and approve or disapprove the DOJ’s fees. In other words, the VICP, the DOJ, and HHS have strong financial levers used to exert control over petitioners’ lawyers and experts. The financial playing field steeply tilts in the government’s favor.

3. THE LACK OF ADEQUATE ACCESS TO EXISTING SCIENCE.

The most important information about vaccine safety is the taxpayer-funded Vaccine Safety Datalink, the government repository of epidemiological data on the vaccine program.11 In the Omnibus Autism Proceeding, which aggregated over five thousand claims, petitioners were not granted adequate access to the Vaccine Safety Datalink information about early thimerosal studies while the DOJ presumably had access.12 Without this data, petitioners’ lawyers were at a severe disadvantage in making their argument for a thimerosal-autism link. In a normal court, a judge would have compelled access to such critical information as part of the civil discovery process, in which the parties are forced to share relevant information about causation. Because the VICP was not set up as a court to deal with complex questions of causation—it was set up to review recovery for presumptive injuries—it failed to address the heart of the vaccine-autism question.

4. THE ABSENCE OF ESSENTIAL SCIENCE.

In order to prevail in the VICP on a claim of vaccine-induced injury, a petitioner must present a plausible scientific theory, a logical sequence of cause and effect, and a connection in timing between the vaccination and the injury.13 The burden of proving a vaccine-induced injury is on the petitioner. There are many universally acknowledged gaps in vaccine safety science, which leave petitioners without the ability to definitively prove their cases and therefore, without compensation, even when there is no credible explanation for what happened to the child except vaccine-induced injury.

5. THE LACK OF TRANSPARENCY AND THE PERCEPTION OF ARBITRARINESS.

To protect families’ privacy, medical records in the VICP are generally sealed and unavailable. The DOJ may settle cases rather than litigate them and may enter in to stipulations to keep information confidential, as happens in most kinds of civil litigation. The discrepancy between settled cases and dismissed cases leads to an appearance of arbitrariness, with the inability to compare and contrast VICP and DOJ decisions on full, factual records.

For instance, the DOJ appropriately agreed to compensate one child diagnosed with an autism spectrum disorder in the Omnibus Autism Proceeding, based on an individualized expert report.14 The child’s family appears to have received a significant amount of compensation that will cover the enormous cost of caring for the child, who was severely injured.15 The expert report is sealed. This outcome for the family diametrically contrasts with the case of another child in the Omnibus Autism Proceeding, for which the government produced another individualized expert report from the same expert.16 The two expert reports appear to have been completely different in the two cases. In the compensated case, the expert’s report led to compensation for encephalopathy leading to regressive autism. In the uncompensated case, the expert’s report led to a denial of compensation for encephalopathy leading to regressive autism. The lack of transparency in the decision-making process creates an appearance of capriciousness and injustice. It is inexplicable to families with claims and to the public why HHS conceded one case of vaccine-induced autism while aggressively opposing five thousand markedly similar cases of vaccine-induced autism.

6. THE LACK OF DISCOVERY.

Although discovery—a civil court’s ability to require the parties to produce documents, answer questions, and make witnesses available for questioning under oath—is theoretically possible in the VICP, the court is not obligated to make it available. The ability to subpoena documents or witnesses absent a court order is rarely granted. Unlike in normal courts, where civil litigants win and lose on discovery, discovery and subpoena powers are all but absent in the VICP.

7. THE LACK OF ADEQUATE PROCEDURAL SAFEGUARDS.

The VICP does not have normal rules of evidence or civil procedure. While Congress created this informality for the petitioners’ benefit, the lack of rules now severely hampers petitioners. For example, in the Omnibus Autism Proceeding, the DOJ was able to introduce expert reports without producing the underlying data17 and information that almost certainly would have been deemed irrelevant and excluded in a normal court proceeding.18 The VICP’s lack of formal rules for civil procedure and evidence harms petitioners. Despite the lack of evidentiary rules, the VICP has begun to impose standards of admissibility applied in normal courts,19 such as the Daubert rule, which governs the admissibility of scientific evidence. Thus, the full burden of producing proof subject to evidentiary rules is being imposed on petitioners who have neither the resources nor the legal mechanisms through discovery to meet these formidable challenges.

8. THE GOVERNMENT’S LACK OF BURDEN TO PROVE CAUSATION.

The Court of Federal Claims assumes that once the FDA and the CDC have approved vaccines, they are safe. Therefore the government is not required to prove the safety of a vaccine—and the petitioner must demonstrate the harmfulness of a vaccine, even though the U.S. Court of Appeals for the Federal Circuit acknowledges this scientific area is “bereft of complete and direct proof of how vaccines affect the human body.”20 Only when the petitioner has made a very strong case that suggests compensation is necessary does the government have to provide an alternate theory of causation. This burden of proof does not correspond with Congress’s intention to afford parents the presumption of recovery. Congress never intended that parents would litigate every case; on the contrary, they expected that the Vaccine Injury Table would afford families’ presumptions of recovery that would streamline the entire legal process. Congress expected that certain injuries from specific vaccines within certain time frames would lead to almost automatic compensation.

9. THE LACK OF A JURY OF PEERS.

The VICP permits no juries. Most families who have had the misfortune of bringing a claim to the VICP believe that more citizen participation would ensure more fairness. While courts have upheld the constitutionality of the VICP to date, many petitioners who have gone before it consider it to be fundamentally unfair. As one parent with a claim on behalf of her child in the Omnibus Autism Proceeding said,“The deck is stacked against families in Vaccine Court. Government attorneys defend a government program, using government-funded science, before government judges.”21

10. THE INAPPROPRIATELY SHORT STATUTE OF LIMITATIONS.

Petitioners have only three years from the time a vaccine-induced injury occurs to file a claim. The Vaccine Injury Table was set up in a time when it was thought that all vaccine-induced injuries happened immediately. This concept of vaccine-induced injury does not reflect many of the disabilities petitioners allege today—autism, seizure disorders, learning disabilities, arthritis—which are conditions that may appear years after vaccination and that have gradual and indistinct onsets. Furthermore, many doctors are unfamiliar with the emerging scientific evidence linking certain disabilities to vaccines.22 While many lawmakers have proposed a longer statute of limitations, the three-year window remains—and excludes many families who think their children’s injuries were due to vaccines. Even if a claimant is not in a position to know that a vaccine may have caused an injury, the three-year limitation will strictly apply.

The U.S. Supreme Court heard Bruesewitz v. Wyeth, an important vaccine-related case, in October 2010. This case will decide whether petitioners, after they have filed in the VICP, may then file a claim in a normal court if they suspect a vaccine had a design defect. The petitioner, Hannah Bruesewitz, sued in the VICP with the intention of receiving compensation for permanent injuries caused by a diphtheria-pertussis-tetanus (DPT) vaccine. She developed a severe seizure disorder as an infant immediately after receiving a DPT shot. After litigating and losing in the VICP, she sued in a Pennsylvania civil court, arguing that the DPT vaccine’s design was defective and unreasonably dangerous. A Pennsylvania federal district court and the Third Circuit Court of Appeals decided that Bruesewitz had no right to bring the claim to civil court. In their view, the Act preempted or precluded her claim. The Supreme Court will have to decide whether Bruesewitz has this right.

The Supreme Court’s decision could have a major impact on vaccine law and safety. This decision may determine whether there are effective judicial checks on defectively designed vaccines. If vaccine-injured individuals have no recourse in civil courts, then what protection does the public have against defectively designed vaccines? As Supreme Court Justice Sotomayor asked during the Bruesewitz hearing, “What is the inducement for them [the vaccine industry] to do it [fix defective vaccine designs] voluntarily?”23

Congress should radically reform the VICP or abolish it. The Act has failed to achieve its primary goals—to compensate for vaccine-induced injuries and to make vaccines safer. The VICP has achieved only its third goal—to insulate industry and medical professionals from liability for vaccine-induced injuries. In that area, the Act has succeeded, at the grave expense of vaccine-injured children.

Footnotes

1 The 1986 National Childhood Vaccine Injury Act acknowledges that vaccine injury or death may be “unavoidable even though the vaccine was properly prepared and accompanied by proper directions and warnings.” 42 U.S.C. 300aa-22(b)(1). The “unavoidable” language in the Act is from the Restatement (Second) of Torts that applies to “products which, in the present state of human knowledge, are quite incapable of being made safe.” Restatement (Second) of Torts Section 402A, comment k (1965).

2 According to the Centers for Disease Control and Prevention, “[y]ears of testing are required by law before a vaccine can be licensed. Once licensed and in use, vaccines are continuously monitored for safety and efficacy,” www.cdc.gov/vaccine-safety/Vaccines/Index1.html.

6 For example, Dr. Martin Smith, the President of the American Academy of Pediatrics, wrote in an article about the 1986 act to his members that “[t]his was the best compromise settlement . . . that could be reached.” Martin H. Smith, National Childhood Vaccine Injury Act, Pediatrics 82 (1988):264. From a different perspective, Barbara Loe Fisher, President of the National Vaccine Information Center, said in an address to the Advisory Commission on Childhood Vaccines about the work of parents in crafting the 1986 Act, “[w]e believed we were participating in the development of a law which would give—in the words of the then AAP Chairman—‘simple justice to children,’” www.nvic.org/injury-compensation/vaccineinjury.aspx.

9 The Omnibus Autism Proceeding was a set of six test cases chosen from approximately 5,000 petitions to determine whether vaccines caused autism in those cases. The cases lasted approximately eight years, presenting thousands of pages of science and testimony and tens of witnesses on two theories, that the mercury-containing preservative thimerosal causes autism alone and that thimerosal together with the measles-mumps-rubella vaccine causes autism, www.uscfc.uscourts.gov/sites/default/files/autism.background.2010_0.pdf.

10 To be sure, there is evidence that individual Special Masters exercise appropriate independence. Our critique is directed to the VICP as an institution and not to the performance of individual Special Masters.

12 Institute of Medicine, “Vaccine Safety Research, Data Access, and Public Trust,” www.iom.edu/Reports/2005/Vaccine-Safety-Research-Data-Access-and-Public-Trust.aspx, noting that the CDC’s handling of the VSD thimerosal data suffered from a “lack of transparency,” that datasets “were not archived in a standard manner,” and “are not available for reanalysis,” and that CDC officials should “seek legal advice” regarding possible violations of the Federal Data Quality Act. The critical VSD information is allegedly available offshore in the archives of a private healthcare provider. The Special Masters of the Court of Federal Claims presumably could have issued subpoenas for this information but did not. For a detailed discussion of the VSD and the possible thimerosal-autism link, see David Kirby, Evidence of Harm: Mercury in Vaccines and the Autism Epidemic: A Medical Controversy (New York: St. Martin’s Press, 2005).

17 The Special Master in the VICP admitted DOJ’s expert report of Dr. George Bustin without admitting the underlying data verifying his expert report. This data was crucial to the final decision that Michelle Cedillo’s autism was not caused by the measles virus. The judges of the U.S. Court of Appeals for the Federal Circuit acknowledged that the lack of underlying data for the Bustin report was “troubling,” but did not require that the data be produced in part because the formal rules of civil procedure do not apply. Cedillo v. HHS, 2010 5004, (Fed. Cir. August 27, 2010), www.cafc.uscourts.gov/images/stories/opinions-orders/10-5004.pdf.

18 In the Omnibus Autism Proceeding, DOJ frequently referred to Dr. Andrew Wakefield’s character and laboratory, although he was not a party to the litigation and had no direct relevance to it. DOJ had Dr. Chadwick testify because Dr. Chadwick had worked in Dr. Wakefield’s laboratory, although he had no knowledge about the laboratory where Michelle Cedillo’s measles biopsy laboratory analyses were actually done. Cedillo v. HHS, 2009 WL 331968 at 56. Similarly, in closing arguments DOJ’s lead attorney Vincent Matanoski stated that “all the strands through these cases come back to him [Andrew Wakefield]. He presented bad science.” Cedillo Transcript, June 26, 2007, 2898-99 at A599– A600.